Trial Outcomes & Findings for Sodium Bicarbonate Supplementation in Chronic Kidney Disease Evaluation of Dose Response, Safety and Beneficial Effects (NCT NCT00888290)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

20 participants

Primary outcome timeframe

8 weeks

Results posted on

2022-08-30

Participant Flow

Patients will receive both active treatment and placebo. Therefore the 20 patients who started placebo also started active treatment. There are only 20 participants total in the study.

Participant milestones

Participant milestones
Measure	All Participants Sequential design. Participants all began with taking placebo for 2 weeks and started sodium bicarbonate using escalating doses of sodium bicarbonate with a dose increase every 2 weeks (0.3 mEq/kg of ideal body weight, 0.6 mEq/kg of ideal body weight and 1 mEq/kg pf ideal body weight).
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sodium Bicarbonate Supplementation in Chronic Kidney Disease Evaluation of Dose Response, Safety and Beneficial Effects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=20 Participants All participants went through sequential dosing of placebo, then sodium bicarbonate escalating doses.
Age, Continuous	63.1 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity · Black	11 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity · Hispanic	9 Participants n=5 Participants
Systolic Blood Pressure	134 mm Hg STANDARD_DEVIATION 13 • n=5 Participants
Diastolic Blood Pressure	70 mm Hg STANDARD_DEVIATION 7 • n=5 Participants
Serum Bicarbonate Levels	23.0 mEq/L STANDARD_DEVIATION 2.4 • n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Outcome measures

Outcome measures
Measure	Sodium Bicarbonate n=20 Participants Crossover design. Participants will be getting different doses of sodium bicarbonate during the study. Sodium bicarbonate: Sodium bicarbonate at 3 different doses or placebo. The different doses tested will be: 0.3 mEq/kg of ideal body weight, 0.6 mEq/kg of ideal body weight and 1 mEq/kg pf ideal body weight	Placebos n=20 Participants Crossover design. Participants will be getting either placebo of different doses during the study. Placebos: Placebo at 3 different doses to match Sodium bicarbonate dosing
Serum Bicarbonate Levels	25.5 mEq/L Standard Deviation 2.3	22.2 mEq/L Standard Deviation 2.8

SECONDARY outcome

Timeframe: 8 weeks

10 repetition sit-to-stand test

Outcome measures

Outcome measures
Measure	Sodium Bicarbonate n=20 Participants Crossover design. Participants will be getting different doses of sodium bicarbonate during the study. Sodium bicarbonate: Sodium bicarbonate at 3 different doses or placebo. The different doses tested will be: 0.3 mEq/kg of ideal body weight, 0.6 mEq/kg of ideal body weight and 1 mEq/kg pf ideal body weight	Placebos n=20 Participants Crossover design. Participants will be getting either placebo of different doses during the study. Placebos: Placebo at 3 different doses to match Sodium bicarbonate dosing
Muscle Strength as Measured by sit-to Stand Test	22.2 Seconds Standard Deviation 1.6	23.8 Seconds Standard Deviation 1.4

SECONDARY outcome

Timeframe: 8 weeks

Outcome measures

Outcome measures
Measure	Sodium Bicarbonate n=20 Participants Crossover design. Participants will be getting different doses of sodium bicarbonate during the study. Sodium bicarbonate: Sodium bicarbonate at 3 different doses or placebo. The different doses tested will be: 0.3 mEq/kg of ideal body weight, 0.6 mEq/kg of ideal body weight and 1 mEq/kg pf ideal body weight	Placebos n=20 Participants Crossover design. Participants will be getting either placebo of different doses during the study. Placebos: Placebo at 3 different doses to match Sodium bicarbonate dosing
Systolic Blood Pressure	127 mmHg Interval 121.0 to 133.0	129 mmHg Interval 122.0 to 139.0

Adverse Events

Sodium Bicarbonate

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebos

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Sodium Bicarbonate n=20 participants at risk Crossover design. Participants will be getting different doses of sodium bicarbonate during the study. Sodium bicarbonate: Sodium bicarbonate at 3 different doses or placebo. The different doses tested will be: 0.3 mEq/kg of ideal body weight, 0.6 mEq/kg of ideal body weight and 1 mEq/kg pf ideal body weight	Placebos n=20 participants at risk Crossover design. Participants will be getting either placebo of different doses during the study. Placebos: Placebo at 3 different doses to match Sodium bicarbonate dosing
Cardiac disorders Shortness of breath	10.0% 2/20 • 8 weeks	5.0% 1/20 • 8 weeks

Additional Information

Michal Melamed

Albert Einstein College of Medicine

Phone: 718-430-2496

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place